Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01929018
Eligibility Criteria:
Inclusion Criteria:
1. Diabetes and/or Peripheral Artery Disease
2. Unilateral transtibial amputation \< 6 months prior to screening
3. Household ambulation using definitive prosthesis prior to baseline testing
4. Participation in physical rehabilitation at time of baseline testing
5. Live within 45 minutes of a participating clinic
Exclusion Criteria:
1. Require wheelchair for mobility (use prosthesis for transfers only)
2. Ankle-level or above amputation on contralateral limb
3. Traumatic or cancer-related amputation
4. Uncontrolled heart condition
5. Acute systemic infection
6. Pregnancy
7. Decisionally challenged
8. Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01929018
Study Brief:
Protocol Section:
NCT01929018